Senior Regulatory and Start Up Specialist

Precision for Medicine; Birmingham; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading company in clinical research is seeking a Senior Regulatory and Start Up Specialist to ensure timely site activation and compliance with local regulations. This fully home-based role involves managing submissions and collaborating with various stakeholders to facilitate clinical trials. Ideal candidates will have a strong background in regulatory processes and excellent communication skills.

Qualifications

• At least 3.5 years of experience as a Regulatory or Start-Up specialist.
• Experience with UK regulatory and start-up processes preferred.

Responsibilities

• Ensure timely site activation readiness and manage risks.
• Prepare Clinical Trial Application Forms and submission dossiers.
• Maintain communication with key functions involved in country start-up activities.

Skills

Communication

Organizational Skills

Fluency in English

Education

Bachelor's degree in life sciences

RN qualification

Tools

Computerized Systems

Spreadsheets

Email

Job description

Precision for Medicine is not your typical CRO. At Precision for Medicine, we leverage new technologies, expertise, and operational scale to enhance the speed, cost, and success rate of bringing life-changing therapies to patients. Our unique approach integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.

Position: Senior Regulatory and Start Up Specialist

Location: UK (fully home-based)

Essential Functions:

1. Ensure timely and high-quality site activation readiness within assigned countries/sites, proactively managing risks.
2. Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments/notifications) for submission to CA, EC, and other local bodies, ensuring compliance with local requirements and timelines.
3. Interact with CA/EC for study purposes and handle responses efficiently.
4. Provide regular updates on CA and EC submissions to relevant stakeholders.
5. Maintain project plans, trackers, and regulatory intelligence tools, updating Regulatory Leadership as needed.
6. Support the development of start-up plans, IMP release requirements, and document review criteria.
7. Collaborate with site CRAs to ensure alignment and secure site collaboration.
8. Manage collection and review of essential documents for site activation and IMP release.
9. Customize country/site-specific Patient Information Sheets and Informed Consent Forms.
10. Coordinate translations of documents for submission.
11. Maintain communication with key functions involved in country start-up activities.
12. Act as SME for critical path data points related to site activation, including timelines and review requirements.
13. Support study budget negotiations and investigator contract execution as needed.
14. Stay updated on local clinical trial laws and regulations, disseminating this knowledge within PfM.
15. Maintain audit/inspection readiness and file documents according to TMF plans.
16. Support Pre-Study Site Visits and feasibility assessments.
17. Assist in developing country-specific start-up summaries and process flows.
18. Develop training sessions to expand knowledge and act as SME for queries.
19. Mentor staff on local regulations, submissions, and procedures.
20. Engage with clients to provide status updates and participate in proposal activities.
21. Perform other duties as assigned.

Qualifications:

Minimum Required:

• Bachelor's degree in life sciences, healthcare, or RN qualification, or equivalent experience.
• At least 3.5 years of experience as a Regulatory or Start-Up specialist in CRO or pharmaceutical/biotech industry.

Other Required:

• Excellent communication and organizational skills.
• Proficiency with computerized systems, spreadsheets, and email.
• Fluency in English.
• Ability to prioritize and meet deadlines.

Preferred:

• Experience with UK regulatory and start-up processes.
• Knowledge of milestone tracking tools.
• Ability to mentor junior staff.
• Advanced degrees or certifications (MD, PhD, PharmD, RAC, etc.).
• Knowledge of GCP/ICH guidelines.
• Strong attention to detail and communication skills.
• Flexibility and willingness to travel occasionally.

We are committed to equal opportunity employment and providing accommodations for individuals with disabilities. For inquiries, please contact QuestionForHR@.